Bulk fibers such as psyllium and methylcellulose are known effective laxatives. Bulk fiber laxatives are often powders which are mixed in water and consumed. Another type of laxative is a stimulant laxative, which is typically available in tablet or capsule form. These include senna, phenolphthalein, casanthranol, and bisacodyl.
Benefits of bulk laxatives relative to stimulant laxatives include: mildness, naturalness, minimal to no diarrhea, and/or a more normal, bulked bowel movement. However, bulk laxatives traditionally work slower than stimulant laxatives. Although stimulant laxatives can be harsh and are sometimes associated with cramping, the constipated person is often quite uncomfortable and does not want to wait the several days it may take for a bulk fiber to provide relief. Stimulant laxatives ordinarily provide overnight relief from constipation. An ideal laxative would be one which provides the benefits of bulk fiber, yet also provides speed to relief.
The active ingredient in some commercially available stool softeners is dioctyl sulfosuccinate, which is an anionic medicinal surfactant. Dioctyl sulfosuccinates combined with stimulant laxatives such as phenolphthalein, casanthranol, and senna are permitted active ingredients, according to the Federal Register, vol. 40, No. 56, Part II Over-the-Counter-Drugs, "Proposed Establishment of Monographs for OTC Laxative, Antidiarrheal, Emetic and Antiemetic Products", p. 12941. Also included therein is dioctyl sulfosuccinate (docusate sodium) in combination with sodium carboxymethylcellulose. It is believed that there is no commercially available laxative composition with both dioctyl sulfosuccinate and the bulk fibers herein as the active ingredients.
It has been found by the present invention that bulk fibers, particularly psyllium, methylcellulose, polycarbophil, calcium polycarbophil, bran, malt soup extract, karaya, guar gum, and mixtures thereof, can be combined with dioctyl sulfosuccinate to provide a laxative with surprisingly increased speed to relief. Benefits of this combination can include gentle relief, making bowel movements easier to pass, relief of constipation, causing predictable results, good signal to go, complete relief and/or a normal, bulked bowel movement.
A problem, though, with including dioctyl sulfosuccinate in ingestible laxative compositions, particularly those which are to be masticated, is the bad taste of this anionic surfactant. This bitter taste is a particular problem in laxative drink mixes, chewable tablets and food forms containing dioctyl sulfosuccinate. A process has therefore now been invented by which can been invented by which an ingestible, neutral tasting laxative composition containing dioctyl sulfosuccinate can be made.
This process has the advantage of making a composition which is effective for treating constipation, and which, even though it contains dioctyl sulfosuccinate, is not bad tasting. By this process, the encapsulated dioctyl sulfosuccinate is not tasted in the mouth, yet it is available in the gastrointestinal tract to aid in the relief of constipation.
A further advantage of this process is its use in making a dioctyl sulfosuccinate-containing composition for use as a medicinal drug which minimizes or eliminates the stomach disturbances, such as nausea, which can be side effects of taking dioctyl sulfosuccinate.